BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 13008736 · Received December 15, 2021

    Report

    Report Number
    3003768277-2021-10274
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 19, 2021
    Report Date
    December 9, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085251
    PMA / PMN Number
    K172822
    Removal / Correction Number
    3003768277- 2021/10/29-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE WIRELESS CONNECTION WITH THE BASE STATION WAS RE-ESTABLISHED AFTER RESTARTING THE SYSTEM. PHILIPS HAS CONFIRMED THAT THE REPORTED FAILURE IS DUE TO A CONNECTIVITY ISSUE. DUE TO A FIRMWARE BUG THE WIRELESS FOOT SWITCH CAN SUDDENLY STOP RESPONDING WHEN A NUMBER OF AMBIENT CONDITIONS COEXIST, SUCH AS EMC DISTURBANCE AND THE PRESENCE OF OTHER WIRELESS DEVICES IN THE ROOM. PHILIPS HAS INITIATED A MEDICAL DEVICE CORRECTION/FIELD SAFETY CORRECTIVE ACTION (2021-IGT-BST-020). PHILIPS HAS ATTEMPTED TO OBTAIN PATIENT INFORMATION. THE CUSTOMER DID NOT RECALL THE PATIENT DETAILS. NO PATIENT INFORMATION COULD BE OBTAINED.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED TO PROVIDE THE LINKAGE TO AN EXISTING CORRECTION & REMOVAL (3003768277- 2021/10/29-004-C). THE REPORTED EVENT OCCURRED PRIOR TO COMPLETION OF THE CORRECTION & REMOVAL 3003768277- 2021/10/29-004-C, WHICH ADDRESSES THE CAUSES ASSOCIATED WITH THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A PLANNED TREATMENT PROCEDURE THE WIRELESS FOOTSWITCH LOST CONNECTION WITH THE BASE STATION AND THE WIFI INDICATOR WAS RED. THE PROCEDURE WAS COMPLETED USING THE WIRED FOOTSWITCH. NO HARM TO THE PATIENT HAS BEEN REPORTED TO PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908300 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838085251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown